Clinical Trial: Navigant Study- Treatment Patterns in mCRPC (Metastatic Castrate Resistant Prostate Cancer )
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational
Official Title: Current Management, Treatment Patterns and Outcomes of Metastatic Castrate Resistant Prostate Cancer Patients Treated With Radium-223
Brief Summary: Categorize the clinical parameters and patient determinants that drive physician decision making for treatment selection including Radium-223 for patients with mCRPC.
Detailed Summary: This is a chart review of 200 Xofigo patients to describe sequencing and characterize clinical parameters and patient determinants that drive physician decision making.
Sponsor: Bayer
Current Primary Outcome: Determining factors that drive physician decision for treatment selection. [ Time Frame: Up to 9 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Most common treatment sequences [ Time Frame: Up to 9 months ]Description of what treatments are given to treat mCRPC in first, second, third, and fourth line.
- Integration of Xofigo into the common treatment sequences, monotherapy or in combination. [ Time Frame: Up to 9 months ]Describe where is Xofigo given in the treatment paradigm, whether is given in combination with hormonals or chemotherapy or given as a monotherapy
- Mean Xofigo dose [ Time Frame: Up to 9 months ]Mean dose of each treatment received in the respective sequence
- Duration of Xofigo treatment [ Time Frame: Up to 9 months ]Mean number of treatment cycles
- Overall survival (OS) [ Time Frame: Up to 9 months ]Collect outcomes for patients following treatment for mCRPC including changes in overall survival
- Time to radiographic progression [ Time Frame: Up to 9 months ]Collect outcomes for patients following treatment for mCRPC including changes in time to radiographic progression
- Time to PSA (Prostate specific antigen) progression [ Time Frame: Up to 9 months ]Collect outcomes for patients following treatment for mCRPC including changes in PSA progression
- Most common SRE (Skeletal Related Event) [ Time Frame: Up to 9 months ]The SRE occurring in the highest number of participants will be described.
- Most common clinical intervention [ Time Frame: Up to 9 months ]Most common clinical intervention to treat SRE/SSEs such as radiation or bone surgery.
- Time to first SSE(Symptomatic Skeletal Events) [ Time Frame: Up to 9 months ]Time to first SSE outcome will be analysed using the Kaplan Meier method
- Reasons for discontinuation [ Time Frame: Up to 9 months ]The treating physician should select out of the following options: Prostate Specific Antigen rising, Alkaline phosphatase (ALP) , Lactate dehydrogenase (LHD)), testosterone, pain, symptoms, bone lesions, disease progression.
- Change in laboratory values from baseline [ Time Frame: Up to 9 months ]for hemoglobin, platelets, neutrophils
- Radiological progression free survival (rPFS) [ Time Frame: Up to 9 months ]change in laboratory values from baseline for radiological progression free survival (rPFS)
- Time to alkaline phosphatase (ALP) progression [ Time Frame: Up to 9 months ]change in laboratory values from baseline for ALP
- Time to visceral metastasis [ Time Frame: Up to 9 months ]time from baseline to the appearance of visceral metastasis
- Time to onset of first subsequent treatment [ Time Frame: Up to 9 months ]or start of any other treatment for mCRPC
- Pain [ Time Frame: Up to 9 months ]Based on chart reported pain
- Most common symptoms [ Time Frame: Up to 9 months ]The participant and the treating physician should select out of the following list: fatigue, hypertension, cognitive disorder, seizures, edema, hypokalemia, cardiac disorders, hepatotoxicity, anemia, neutropenia, febrile neutropenia, thrombocytopenia
- Type of physician [ Time Frame: Up to 9 months ]Define type of physicians that treat of mCRPC
- Change in PSA from baseline to 12 weeks, and baseline to discontinuation [ Time Frame: Baseline and 12 weeks,Baseline and through study completion, an average of 1 year ]Measure PSA closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuation
- Resource utilization [ Time Frame: Up to 9 months ]Number of outpatient, inpatient and emergency room visits as well as number of hospitalizations
- Change in ALP from baseline to 12 weeks, and baseline to discontinuation [ Time Frame: Baseline and 12 weeks,Baseline and through study completion, an average of 1 year ]Measure ALP closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinu
Original Secondary Outcome:
- Most common treatment sequences [ Time Frame: Up to 9 months ]Description of what treatments are given to treat mCRPC in first, second, third, and fourth line.
- Integration of Xofigo into the common treatment sequences, monotherapy or in combination. [ Time Frame: Up to 9 months ]Describe where is Xofigo given in the treatment paradigm, whether is given in combination with hormonals or chemotherapy or given as a monotherapy
- Mean Xofigo dose [ Time Frame: Up to 9 months ]
- Duration of Xofigo treatment [ Time Frame: Up to 9 months ]Mean number of treatment cycles
- Overall survival (OS) [ Time Frame: Up to 9 months ]
- Time to radiographic progression [ Time Frame: Up to 9 months ]
- Time to PSA (Prostate specific antigen) progression [ Time Frame: Up to 9 months ]
- Most common SRE (Skeletal Related Event) [ Time Frame: Up to 9 months ]The SRE occurring in the highest number of participants will be described.
- Most common clinical intervention [ Time Frame: Up to 9 months ]Most common clinical intervention to treat SRE/SSEs such as radiation or bone surgery.
- Time to first SSE(Symptomatic Skeletal Events) [ Time Frame: Up to 9 months ]
- Reasons for discontinuation [ Time Frame: Up to 9 months ]The treating physician should select out of the following options: Prostate Specific Antigen rising, Alkaline phosphatase (ALP) , Lactate dehydrogenase (LHD)), testosterone, pain, symptoms, bone lesions, disease progression.
- Change in laboratory values from baseline [ Time Frame: Up to 9 months ]for hemoglobin, platelets, neutrophils
- Radiological progression free survival (rPFS) [ Time Frame: Up to 9 months ]
- Time to alkaline phosphatase (ALP) progression [ Time Frame: Up to 9 months ]
- Time to visceral metastasis [ Time Frame: Up to 9 months ]
- Time to onset of first subsequent treatment [ Time Frame: Up to 9 months ]or start of any other anticancer treatment
- Pain [ Time Frame: Up to 9 months ]Based on chart reported pain
- Most common symptoms [ Time Frame: Up to 9 months ]The participant and the treating physician should select out of the following list: fatigue, hypertension, cognitive disorder, seizures, edema, hypokalemia, cardiac disorders, hepatotoxicity, anemia, neutropenia, febrile neutropenia, thrombocytopenia
- Type of physician [ Time Frame: Up to 9 months ]Define type of physicians that treat of mCRPC
- Change in PSA from baseline to 12 weeks, and baseline to discontinuation [ Time Frame: Baseline and 12 weeks,Baseline and through study completion, an average of 1 year ]Measure PSA closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuation
- Resource utilization [ Time Frame: Up to 9 months ]Number of outpatient, inpatient and emergency room visits as well as number of hospitalizations
- Change in ALP from baseline to 12 weeks, and baseline to discontinuation [ Time Frame: Baseline and 12 weeks,Baseline and through study completion, an average of 1 year ]Measure ALP closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuation
- Change in LDH from baseline to 12 weeks, and baseline to discontinuation [ Time Frame: Baseline and 12 weeks,Baseline and through study completion, an average of 1 year ]Measure LDH values closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuation
Information By: Bayer
Dates:
Date Received: July 19, 2016
Date Started: July 31, 2017
Date Completion: August 31, 2017
Last Updated: May 15, 2017
Last Verified: May 2017
- Most common treatment sequences [ Time Frame: Up to 9 months ]